cervical cancer
Conditions
Interventions
Intervention group:Induced immune chemotherapy
Sponsors
First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female, aged 18-70 years; 2. Diagnosed with cervical cancer at stage IB3, IIA2, or IIIC1r (tumor diameter >= 4 cm) according to the FIGO 2018 staging system (staging determined by two or more deputy chief-level physicians through gynecological examination), and untreated; 3. At least one measurable target lesion for tumor efficacy assessment based on the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1); 4. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma (common type), or adenosquamous carcinoma; 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. Hematological and liver function parameters meet the following criteria: (1) White blood cell count (WBC) >= 3 × 10^9, (2) Neutrophil count >= 1.5 × 10^9/L, (3) Platelet count (PLT) >= 80 × 10^9/L, (4) AST and ALT <= 1.5 × ULN, (5) Total bilirubin <= 1.5 × ULN, (6) Serum creatinine <= 1.5 × ULN, (7) Blood urea nitrogen <= 1.5 × ULN; 7. Subjects must use effective contraception from the time of signing the informed consent until 180 days after the last chemotherapy; 8. Volunteers for the clinical trial and sign informed consent, which must comply with Good Clinical Practice (GCP) requirements.
Exclusion criteria
Exclusion criteria: 1. Known allergies to any drug or its components used in the experiment or other monoclonal drugs; 2. Active, known or suspected autoimmune diseases requiring systemic treatment, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, and asthma requiring bronchodilator treatment; 3. Diseases that require treatment with systemic corticosteroids (more than 10 mg of prednisone or equivalent daily) or other immunosuppressive drugs (cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-a inhibitors, etc.) within 2 weeks before the first dose of the test drug and during the study period; 4. Previous treatment with immune checkpoint inhibitors, including but not limited to: anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody drugs; 5. Receiving high-dose corticosteroid treatment within 2 weeks before the first dose of the test drug; 6. Subjects with any of the following infection conditions: (1) HIV positive, (2) HBsAg positive with HBV DNA level >= 2000 IU/mL or 10^4 copies/mL, (3) positive HCV antibody and positive HCV RNA, (4) received anti-tuberculosis treatment within 1 year prior to screening; 7. Having other primary malignant tumors except cervical cancer or stage I thyroid cancer within 5 years prior to screening; 8. Pregnancy or lactation; 9. The clinical investigator judges that there are severe non-tumor diseases, dysfunctions, or corresponding therapeutic measures in major organs such as the heart, lungs, gastrointestinal tract, including but not limited to: heart disease with NYHA class III-IV cardiac function, severe/uncontrolled angina, myocardial infarction within 6 months prior to screening, significant ventricular arrhythmias, severe heart failure, poorly controlled hypertension (systolic >= 160 mmHg or diastolic >= 100 mmHg), severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, severe viral infections and septic shock, severe diabetes, immune-related diseases, hematological diseases, or significant surgical history; 10. Received live attenuated vaccines or vaccines within 4 weeks before the first dose of the test drug, excluding inactivated seasonal influenza vaccines; 11. Undergoing allogeneic bone marrow transplantation or solid organ transplantation; 12. Drug or alcohol abuse; 13. Participating in other clinical trials within 30 days prior to screening or during this trial; 14. The investigator deems it inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response rate; | — |
Countries
China
Contacts
Public ContactQingdong Zhang
First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed